Vaginal insert



May 12, 1953 c. KULICK 2,638,093 VAGINAL INSERT Filed Dec. 20. 1949 rf/s ATTORNEY Patented May 12, 1953 UNITED STATES PATENT OFFICE 16 Claims.

This invention pertains to a vaginal insert or instrument.

An object of this invention is the provision of an insert or instrument arranged to be positioned and held within a vagina and exert pressure against a urethra for the positive control of flow therefrom.

Another object of the invention herein described and claimed is the provision of an insert having associated therewith an inflatable and deflatable means for directing and exerting a controlled pressure against a urethra for the positive control of flow therefrom.

A further object of this invention is the provision of an insert or instrument arranged for positioning within a vagina and positively re movably held therein and having means associated therewith for the selective exertion of pressure against a urethra.

The above and numerous other objects of the present invention will become apparent to those skilled in the art to which this invention appertains from the succeeding description considered together with the accompanying drawing which discloses an exemplification of the invention and wherein:

Figure 1 shows a side elevational view of a form of the invention as applied to a portion of the anatomy of a female or woman.

Figure 2 is a front elevational view of the form of the invention illustrated in Figure l and removed from a portion of the anatomy of a female.

Figure 3 is a horizontal sectional view of a form of the invention removed from a portion of the anatomy of a female and considered substantially along the lines 3-3 of Figure 1 looking in the direction of the arrows.

Figure 4 is a vertical sectional view of the form of the invention and considered substantially along the lines 4-4 of Figure 2 looking in the direction of the arrows.

By now considering the various figures of the drawing in detail wherein like reference characters indicate like parts the numeral I is employed to designate, in a. somewhat general manner, an insert, instrument or appliance embodying the present invention. It is of general knowledge among the medical profession that due to certain conditions brought about by known facts, a urethra 2 leading externally from a urinary bladder 3, in certain females or women, has had its control muscles destroyed or rendered useless. Such condition is known as urinary incontinence, and as a result thereof such women have had,

heretofore, to wear constantly napkins for absorbing the constant flow, however intermittent, from the urinary bladder and urethra. This requirement has not only proven extremely embarrassing but as has been experienced, also proved to be extremely uncomfortable and irritating so much so that such persons afflicted do not and cannot live a normal life. The insert, instrument or appliance of the present invention has proven, in practice, the elimination entirely of the necessity of napkins for the purpose above stated and permits the wearer thereof to live an otherwise normal life.

The insert, instrument or appliance may be made of various materials and for the purpose of illustration only, it may be stated herein that imporous materials are preferred for sanitary reasons as well as others which will become apparent to those skilled in the art to which the present invention appertains. The insert or instrument comprises a shank, member or nipple 4 which may be formed of various selected materials and for the purpose of illustration only it may be here stated that the shanks or nipples now in usage are formed of a solid, homogeneous, imporous material such as plastic or plastic com pounds. This chosen material not only adds rigidity to the shank but also prevents it from absorbing and retaining foreign matter. It will, of course, be clearly understood that the shank, nipple or member may, if desired, be made of any selected material and that this application is not limited to plastic as a material for the shank or member. It is further recognized that a vagina in one female will not vary considerably from vaginas of other women and accordingly the insert is of a size and configuration to fit neatly and completely within a vagina. The proper positioning of the insert within a vagina is of extreme importance and in order that a patient may, without skill or elaborate pre-training, properly position the insert at all times, the configuration of the shank, member or nipple, hereinafter described in minute detail, is such that a misappliance of the insert would be extremely uncomfortable and instantly recognized.

Accordingly, the shank or member considered in elevation has an upper extremity 5 and a lower extremity 6 of greater lateral or horizontal extent than an intermediate position 1 thereof and any selected horizontal section of the memher will reveal an ovoid configuration. It may also be here stated that no sharp edges appear in or on the member so that this component will not cause irritation of any part of the anatomy with which it will contact. This ovoid configuration above referred to will assist the vagina in retaining the member in a fixed position and assist in preventing the rotation of the member within the vagina.

The upper extremity of the shank may be of various components but it is preferred to have this upper extremity formed as an integral component of the shank and as such be provided with a cup-shaped depression or pocket having a concave surface 8 somewhat circular in any given horizontal plane and somewhat elliptical in any given vertical plane as clearly illustrated in the drawing. This cup-shaped depression is arranged to receive or bear against a uterus and since the member is urged into a vagina the the cup-shaped depression also functions as a positioning medium for the uterus. By this is meant that should the uterus be misplaced or positioned other than normal the cup-shaped depression will, when urged against the uterus, func tion as a proper positioning means for this part of the anatomy.

The upper extremity of the member is employed as another means for positively and properly positioning the member within the vagina. Toward the accomplishment of the above the extreme upper edge 9 of the shank which may be also be classified, for the purpose of identification, as a periphery of the cup-shaped depression or of the upper extremity, is disposed at an incline with respect to the longitudinal axis of the shank 4. This inclined periphery rises from its lowermost position 10 anteriorly to its highest portion I l posteriorly so that the lowermost portion of the periphery is positioned at the forward portion of the shank. This design or disposition of the periphery lends itself to the normal formation of the anatomy with which it is to be associated and to this extent the lowermost portion is arranged to bear against or come into contact with an anterior fornix l2 while the highest portion is arranged or adapted to bear against or come into contact with a posterior fornix l3. This disposition of the periphery therefore not only insures a proper positioning of the insert but also functions as a means by which the latter is prevented from executing a rotary motion or movement. A rear portion of the shank immediately below the highest portion of the periphery is bulged outwardly as a smooth curve as at M to lend itself to the conformation of that portion of the anatomy with which it is associated. It may be here noted that if the shank is inserted or applied in an improper position, the highest portion II will bear against the anterior fornix and such association will be somewhat painful and thus made readily apparent or obvious to the patient.

The lower extremity of the shank presents a flat surface or wall l5 and is also purposely and preferably inclined with respect to a horizontal plane but in a direction opposed from or different than the inclination of the upper periphery. The lower surface slopes from its highest portion l6 anteriorly or forwardly, downwardly to its lower portion l'l posteriorly or rearwardly. This particular disposition of the lower extremity is thus formed so that the shank may be completely positioned within a vagina with the highest portion or edge [6 just behind the outer urethral orifice l8 and further so that the lowermost portion or edge I! will be located at a posterior commissure just behind an inner surface of a hymenal ring Hi. This latter re- -ing by a balloon or bag 25.

cited portion of the anatomy aids in supporting or retaining the insert or instrument within the Vagina for it forms a shelf on which the shank rests.

Positioned interiorly of the shank or member is a pocket, housing, cage or cavity 2| disposed adjacent the lower end of the shank and immediately above the fiat wall [5 thereof. This pocket extends, Within the shank, from the flat wall upwardly toward the upper extremity to terminate approximately midway between the extremities in a rounded nose or nest 22. The forward or anterior portion of the shank is provided with a window or opening 23 facing horizontally or outwardly of the shank and communicating with what might be considered as a lower portion of the cavity. The window extends transversely for substantially the greater part of the width of the shank cavity and extends vertically a distance less than the full height of the cavity. This window or opening is intended to extend vertically for a distance represented by a substantial length of the urethra and extend horizontally or laterally for an appreciable distance spanning the urethra. It may be stated here that the window is in horizontal alignment with the urethra and accordingly is positioned at the same side or portion of the shank as the periphery lowermost portion l0 and the highest portion [6 of the lower surface so that these three position determining components may be considered in vertical alignment.

Disposed within the cavity is an inflatable or expandable means 24 characterized in the draw- This balloon or bag is removably retained or positioned in the cavity and may be of any desired or selected material but the material preferred is rubber or a rubber compound because of its inherent characteristics. It is further preferred that the balloon or bag be of a configuration or design so that it may, as closely as possible, conform to the interior contour of the cavity and as such it will lend itself admirably well in performing the office for which it is intended. One primary reason for this preferred configuration of the bag or balloon is that it will then be distended only in a direction intended and thereby render its action positive as well as prolong its usefulness.

Extending through the flat surface or wall 15 into the cavity is an orifice 26 for the reception of a tube 21 the latter of which being formed preferably of tubular rubber and has one end thereof secured to and in communication with the bag or balloon. The tube may be of any desired length so long as it extends away from the bag by a length sufficient to provide for the successful operation of the insert. Attached to an outer or free extremity of the tube is a bulb or ball 28 formed of rubber and secured to the tube by any desired means or method so long as it forms a part thereof and to this extent may be formed integrally therewith as illustrated.

After the shank and its related component, the balloon, has been inserted properly in the vagina, a collapsing action of the ball or bulb will cause a current of air to pass through the tube to inflate the balloon. Since the only avenue along which the balloon may expand is through the window, part of the balloon will pass, inflated through the window and occupy the full Window or opening into the cavity or pocket. This inflation of the balloon will tend to urge the entire shank rearwardly in firm engagement with the related wall of the vagina to assist in holding the insert with-- in the vagina and .also. exert pressure against an appreciable area through which the urethra ex: tends. The position of the window of the shank is such that it is in substantial alignment with a symphysis pubis of the pelvis 29 and any pressure exerted by an inflated balloon will be resisted by the pelvis and since the urethra lies in this pressure area between the pelvis and balloon the latter, inflated, will cause a stop in the flow through the urethra.

Various means such as an illustrated snap clamp 30 may be associated with the tube to .pre-v vent the escape of air from an inflated balloon or permit the escape of air therefrom whichever is desired. Accordingly, when it is desired to permit a flow from the urinary bladder a proper manipulation of the snap clamp will result in the hal- Icon being deflated and since the pressure is thus to thus arrest a flow through the urethra and the wearer of the insert may lead an otherwise per fectly normal life.

It is believed convenient but not essential that some means be incorporated in the insert so as to accommodate a menstrual flow and accordingly the shank has extending entirely therethrough a canal or conduit 3|. This conduit starts at the lower area of the cup-shaped depression as at 32 which then places the conduit in alignment with an external orifice 33 of the uterus and continues downwarolythrou'gh the shank spaced from the pocket or cavity thereof to terminate at the fiat surface or 'Wall 15;

From the above it will be noted that various changes and alterations may be made to the illus trated and described construction without departing from the spirit of the present invention or scope of the appended claims.

I claim:

1. A vaginal insert comprising an imporous shank having a cup-shaped depression at its upper limits adapted to fit against a uterus, a rim of said depression being inclined axially of said shank and having an anterior portion at a lower level than a posterior portion thereof, a cavity insaid shank, a window opening anteriorly of said shank, and an inflatable means within said cavity and arranged to be expanded through said window to urge a urethra against a pelvis.

2. A vaginal insert comprising an imporous shank having an upper extremity arrangedto bear against a uterus, said upper extremity being inclined axially of said shank and at a lower level anteriorly than posteriorly, a cavity in said shank, a window communicating with said cavity anteriorly of said shank, and expandable means within said cavity and arranged to be expanded anteriorly through said window to press against a urethra for preventing flow therefrom.

3. A vaginal insert comprising an imporous member having an upper extremity arranged to bear against a uterus, said upper extremity being inclined axially of said shank and at a lower elevation anteriorly than posteriorly, a cavity within said member, a window communicating with said cavity and disposed anteriorly of said member, and inflatable means housed in said cavity and arranged for expansion forwardly through said window for exerting pressure against a urethra.

' 4. A vaginal insert comprising a member-hav a uterus, said upper extremity having a forward edge at a lower elevation axially of said shank than a rearward edge thereof, a confined area within said member, an opening forwardly of said member communicating with said confined area, and inflatable means confined within said area and arranged for expansion through said opening for exerting pressure against a urethra.

5. A vaginal insert comprising a member substantially ovoid in horizontal section and being of a height greater than a thickness thereof, an upper extremity of said member arranged to bear against a uterus, a cavity within said member, a window opening forwardly of said member and communicating with said cavity, and an inflatable element within said cavity and expandable through said window for exerting pressure against a urethra.

6. A vaginal insert comprising a member of imporous material and of a horizontal section substantially ovoid, an upper extremity of said member arranged to bear against a uterus for positioning said member within a vagina, a confined cavity within said member, an opening forwardly of said member and communicating with said cavity, and a removable inflatable element within said cavity and expandable through said openin for exerting pressure against a urethra.

7. A vaginal insert comprising a member of imporous material and having a horizontal section substantially ovoid, an upper extremity of said member disposed at an incline relative to a longitudinal axis of said member and arranged to bear against a uterus for maintaining said' member in a substantially fixed position, a cavity within said member, an opening in said member forwardly thereof and communicating with said cavity, and a removable inflatable element within said cavity and urgable through said opening for exerting pressure against a urethra.

8. A vaginal insert comprising an imporous member being substantially ovoid in horizontal section, a concave cavity at an upper extremity of said member and having a periphery inclined axially of said member for contact with a uterus, an opening extending into said member, and a removable inflatable element within said member and arranged to be expanded through said opening for exerting pressure against a urethra.

9. A vaginal insert comprising an imporous member, a concave surface at an upper extremity of said member and having a periphery inclined with a lower portion of said periphery being at a forward portion of said member, an opening into said member beneath said lower portion of said periphery, and an inflatable element within said member and arranged to be expanded through said opening for exerting pressure against a urethra.

10. A vaginal insert comprising a member 'ovoid in horizontal section, a concave surface different elevations, said extremity being inclined axially of said means and having a lower portion at a forward portion of said means, an opening into said means below said forward portion of said extremity, means within said first named means, and means associated with said second named means for urging the latter outwardly thereof through said opening for exerting pressure against a urethra.

12. A vaginal insert comprising imporous means having an upper extremity disposed at different elevation axially of said means, a lower portion of said upper extremity being at a forward portion of said means, means formed at a lower extremity of first named means for supporting said insert from a posterior commissure, an opening into said first named means below said lower portion of said upper extremity, an inflatable means within said first named means, and means communicating with said inflatable means for inflating and deflating said inflatable means, said inflatable means being arranged to expand outwardly through said opening for exerting pressure against a urethra.

13. A vaginal insert comprising imporous means, an upper extremity of said means arranged to contact a uterus for proper positioning thereof within a vagina, expandable means Within said first named means, said imporous means having an opening intermediate its extremities, and means for expanding said expandable means through said opening for against a urethra.

14. A vaginal insert comprising imporous means, an upper extremity of said imporous means being arranged and constructed for association with a uterus for properly positioning exerting pressure said imporous means within a vagina, expandable means within said first named means, said imporous means having an opening intermediate its extremities, and means arranged for positioning outside of said vagina for enlarging said expandable means through said opening for exerting pressure against a urethra.

15. A vaginal insert comprising a member ovoid in horizontal section, said member having an upper extremity inclined forwardly axially of said member and a correspondingly inclined cervix-receiving cup formed therein, and said member fitting rearwardly between and being held by a posterior fornix and an inner posterior face of a hymenal ring, and inflatable means within said member and expandable forwardly thereof for exerting pressure against a urethra.

16. A vaginal insert comprising a member ovoid in horizontal section, said member having a cervix-receiving cup in an upper extremity thereof, and said member fitting rearwardly between and being held by a posterior fornix and an inner posterior face of a hymenal ring, and inflatable means within said member and expandable forwardly thereof for exerting pressure against a urethra.

GEORGE KULICK.

References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 444,513 Wagner Jan. 13, 1891 604,958 Biesmeyer May 31, 1898 669,910 Ball Mar. 12, 1901 2,101,273 Smith Dec. 7, 1937 2,365,296 Schimpf Dec. 19, 1944 

